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CIMIZT 150 MICROGRAM/30 MICROGRAM TABLETS

Active substance(s): DESOGESTREL / ETHINYLESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER




Cimizt 150/30 Tablets
Desogestrel150 micrograms & Elhin~estradiol30 micrograms

Road all of this loallot carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass non to others.lt may harm
them, even ~their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or phanmacist. This includes any possible
side eflects not listed in this leaflet.
Important things to know about combined hormonal contraceptives (CHCs):
• They are one of the most reliable reversible methods of contraception ~used correctiy.
• They slighUy increase the risk of having a blood clot in the veins and arteries, especially
in the first year or when restarting a combined honmonal contraceptive following a
breakof4ormoreweeks.
• Please be alert and see your doctor if you think you may have symptoms of a blood clot
(see section 2 'Blood Clots").
What is in this leaflet
1. WhatCimizt Tablets are and what they are used for
2. What you need to know baforeyou take ClmlztTablets
3. HowtotakeCimiztTablots
4. Possible side effects
5. HowtostoreCimiztTablots
6. Contents of the pack and other Information
1. WHATCIMIZTTABLETSAREANDWHATTHEYAREUSEDFOR
Cimizt tablet is a combined oral contraceptive, also called the pill. Each tablet contains a
small amount of two types of female honmones, namely, a progestogen, desogestrel and an
oestrogen, ethinylestradiol.

Cimizt 150/30 Tablets
Desogestrel150 micrograms &
Ethinylestradiol 30 micrograms

These help to stop you from getting pregnant, just as your natural honmones would stop you
conceiving again when you are already pregnant.
The combined contraceptive pill protects you against getting pregnant in three ways. These
honnones:
1. stop the ovary from releasing an egg each month (ovulation),
2. thicken the fluid al the neck ofthe womb making it more difficult for the spenm to reach
the egg,
3. alter the lining of the womb to make it less likely to accept afertilised egg.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIMIZTTABLETS
General notes
Before you start using Cimizt Tablets you should read the infonmation on blood clots in
section 2. lt is particularly important to read the symptoms of a blood clot - see Section 2
'Blood Clots").

PHARMACODE

Before you can begin laking Cimizt Tablets, your doctor will ask you some questions about
your personal health history and that of your dose relatives. The doctor will also measure
your blood pressure, and depending upon your personal situation, may also carry out some
other tests.
In this leaflet, several situations are described where you should stop using Cimizt Tablets,
or where the reliability of the pill may be decreased. In such situations you should enher not
have sex, or you should take extra non-honmonal contraceptive precautions (e.g. use a
condom or another barrier method). Do not use rhythm or temperature methods. These
methods can be unreliable because Cimizt Tablets alters the monthly changes of body
temperature and of cervical mucus.
Cimizt Tablets, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any othersexualtytransmilled disease.
Do not lake tablets
You should not use Cimizt Tablets ~you have any of the conditions listed below. If you do
have any of the conditions listed below, you must tell your doctor. Your doctor will discuss
with you whatotherfonm of birth control would be more appropriate:
• ~you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein
thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
• ~you know you have a disorder affecting your blood clotting - for instance, protein C
deficiency, protein S deficiency, antithrombin-Ill deficiency, Factor V Leiden or
antiphospholipid antibodies;
• ~you need an operation or if you are off your feet for a long time (see section 'Blood
Clots');











if you have ever had a heart attack or a stroke;
if you have (or have ever had) angina pectoris (a condition that causes severe chest
pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA temporary stroke symptoms);
if you have any of the following diseases that may increase your risk of a clot in the
arteries:
severe diabetes with blood vessel damage,
• very high blood pressure,
• avery high level offal in the blood (cholesterol ortriglycerides),
• a condition known as hyperhomocysteinaemia,
if you have (or have ever had) atype of migraine called 'migraine with aura';
if you have (or have ever had) an inflammation of the pancreas (pancreatitis);
if you have (or have ever had) a liver disease and yourliverfunction is still not nonmal;
if you have (or have ever had) atumour in the liver;
if you have (or have ever had) or if you are suspected to having breast cancer or cancer
of the genital organs;
if you have any unexplained bleeding from the vagina;
if you are allergic to ethinylestradiol or desogestrel, or any of the other ingredients of
this medicine (listed in section 6).

Warnings and precautions
When should vou conlactvourdoctor?
Seek urgent medical attention
• if you notice possible signs of a blood clolthat may mean you are suffering from a blood
dot in the leg (i.e. deep vein thrombosis), a blood dol in the lung (i.e. pulmonary
embolism), a heart attack ora stroke (see 'Blood Clot' (thrombosis) section below).
For a description of the symptoms of these serious side effects please go to 'How to
recognise a blood cl or
In some situations you need to take special care while using Cimizt Tablets or any other
combination pill, and your doctor may need to examine you regulariy.
Tell your doctor if any of the following conditions apply to you.
If any of the following conditions applies to you, tell your doctor before starting to use Cimizt
Tablets. Also ~any of the following applies or if any of the conditions develops or worsens
while you are using CimiztTablets consult your doctor.
• if a close relative has or has ever had breast cancer,
• if you have a disease of the liverorthe gallbladder;
• if you have diabetes;
• ifyouhavedepression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have haemolytic uraemic syndrome (HUS -a disorder of blood clotting causing
failure ofthe kidneys);
• ~you have siclde cell anaemia (an inherited disease of the red blood cells);
• ~you have epilepsy (see "Other medicines and CimiztTablets");
• ~ you have systemic lupus erythematosus (SLE - a disease affecting your natural
defence system);
• ~you have elevated levels of fat in the blood (hypertriglyceridaemia) ora positive family
history for this condition. Hypertriglyceridaemia has been associated with an increased
risk of developing pancreatitis (inflammation of the pancreas);
• ~you need an operation, or you are otfyourfeetfora long time (see in section 2 'Blood
Clots');
• ~you have just given birth. In this case you are at an increased risk of blood clots. You
should ask your doctor how soon after delivery you can start laking Cimizt;
• ~you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• ~youhavevaricoseveins;
• ~ you have a disease that first appeared during pregnancy or eariier use of sex
honmones (for example, hearing loss, a blood disease called porphyria, skin rash wnh
blisters during pregnancy (gestational herpes) a nerve disease causing sudden
movements ofthe body (Sydenham's chorea);
• ~you have or have ever had chloasma (a discoloration of the skin especially of the face
or neck known as "pregnancy patches').lf so, avoid direct sunlight or ultraviolet light;
• ~you have hereditary angioedema. In this case products containing oestrogens may
cause or worsen symptoms. You should see your doctor immediately ~you experience
symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty
swallowing or hives together with difficulty in breathing.
Blood Clots
Using a combined honmonal contraceptive such as Cimizt increases your risk of developing
a blood clot compared with not using one.ln rare cases a blood clot can block blood vessels
and cause serious problems.
Blood clots can develop:
• in veins (refemed to as a 'venous thrombosis', 'venous thromboembolism' orVTE).
• in the artaries (referred to as an 'arterial thrombosis', 'artarialthromboembolism' or
ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious lasting
effects or, very rarely, they may be fatal.

Ris important to remember that the overall risk of a harmful blood clot due to Cimizl
Is small.
How to recognise ablood clot
Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of those signs?


swelling of one leg or along a vein in the
leg or foot especially when accompanied
by:
• pain or tenderness in the leg which may
be felt only when standing or walking
• increased wanmth in the affected leg
• change in colour of the skin on the leg
e.g. turning pale, red or blue.
• sudden unexplained breathlessness or
rapid breathing;
• sudden cough without an obvious cause,
which may bring up blood;
• sharp chest pain which may increase with
deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach;
If you are unsure, talk to a doctor as some of
these symptoms such as coughing or being
short of breath may be mistaken for a milder
condition such as a respiratory tract infection
(e.g. a 'common cold').
Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision.
• chest pain, discern rt, pressure,
heaviness;
• sensation of squeezing or fullness in the
chest, anm or below the breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the
back, jaw, throat, anm and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness
of breath;
• rapid or irregular heartbeats.
• sudden weakness or numbness of the
face, anm or leg, especially on one side of
the body;
• sudden confusion, trouble speaking or
understanding;
• sudden trouble seeing in one or both

What are you possibly suffering
from?
Deep vein thrombosis

Pulmonary embolism




When is the risk of developing ablood clot in avein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a
combined honmonal contraceptive forthefirsttime. The risk may also be higher if you restart
laking a combined hormonal contraceptive (the same product or a different product) after a
breakof4weeksormore.
After the first year, the risk gets smaller but is always slightly higher than if you were not
using a combined honmonal contraceptive.
When you stop Cimiztyourriskof a blood clot returns to nonmal within afew weeks.

The overall risk of a blood clot in the leg or lung (DVT or PE) wnh Cimizt is small.

Retinal vein thrombosis (blood clot in
the eye)




Heart attack

Stroke



Out of 10,000 women who are not using any combined honmonal contraceptive and are
not pregnant, about2will develop a blood dot in a year.
Out of 10,000 women who are using a combined hormonal contraceptive that contains
levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a
year.
Out of 10,000 women who are using a combined hormonal contraceptive that contains
desogestrel, such as Cimizt, about9 -12 women will develop a blood dot in a year.
The risk of having a blood clot will vary according to your personal medical history (see
'Factors that increase your risk of a blood clor below).

Women who are not using a combined
honmonal piiVpatch/ring and are not
pregnant
Women using a combined honmonal
contraceptive pill containing
levonorgestrel, norethlsterone or
no estimate
Women using Cimizt

Risk of developing a blood clot in a
ear
About2 out of 10,000 women

About 5-7 out of 10,000women

About9-12 out of 10,000 women

Factors that increase your risk of ablood clot in a vein
The risk of a blood dot wnh Cimizt is small but some conditions will increase the risk. Your
risk is higher:
• if you are very overweight (body mass index or BMI over30kg/m~;
• if one of your immediate family has had a blood dot in the leg, lung or other organ at a
young age (e.g. below the age of about 50 years). In this case you could have a
hereditary blood clotting disorder,
• if you need to have an operation, or ~you are offyourfeetfor a long time because of an
injury or illness, or you have your leg in a cast. The use of Cimizt may need to be
stopped several weeks before surgery or while you are less mobile. If you need to stop
Cimiztaskyourdoctorwhen you can start using nagain;
• as you get older (particularly above the age of about 35 years);
• ifyougavebirth lessthanafewweeksago.

sudden trouble walking, dizziness, loss of
balance or coordination;
sudden, severe or prolonged headache
wnh no known cause;
loss of consciousness or fainting with or
wnhout seizure.

Sometimes the symptoms of stroke can be
brief with an almost immediate and full
recovery, but you should still seek urgent
medical attention as you may be al risk of
another stroke.
• swelling and slight blue discolouration of
an extremity;
• severe pain in your stomach (acute
abdomen).

What can happen if a blood clot forms in avein?
• The use of combined honmonal contraceptives has been connected with an increase in
the risk of blood dots in the vein (venous thrombosis). However, these side effects are
rare. Most frequently, they occur in the first year of use of a combined honmonal
contraceptive.
• If a blood dot fonms in a vein in the leg or foot il can cause a deep vein thrombosis
(DVT).
• If a blood dol travels from the leg and lodges in the lung it can cause a pulmonary
embolism.
• Very rarely a dot may fonm in a vein in another organ such as the eye (retinal vein
thrombosis).

What is the risk of developing ablood clot?
The risk depends on your natural risk of VTE and the type of combined honmonal
contraceptive you are laking.

eyes;


Blood clots in avein

Blood dots blocking other blood
vessels

The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood dot, particulariy if you
have some of the other factors listed.
lt is important to tell your doctor ~ any of these conditions apply to you, even if you are
unsure. Your doctor may decide that Cimizt needs to be stopped.

If any of the above conditions change while you are using Cimizt, for example a dose family
member experiences athrombosis for no known reason, or you gain a lot ofweight, tell your
doctor.
Blood clots in an artery
What can hapoen if ablood clot forms in an arterv?
Like a blood dot in avein, a clot in an artery can cause serious problems. For example, it can
cause a heart attack or a stroke.
Factors that increase your risk of ablood clot in an artery
lt is important to note that the risk of a heart attack or stroke from using Cimizt is very small
but can increase:
• wnh increasing age (beyond the age of about35 years);
• if you smoke. When using a combined honmonal contraceptive like Cimizt you are
advised to stop smoking.lfyou are unable to stop smoking and are older than 35 your
doctor may advise you to use a different type of contraceptive;
• ~youareoverweight;
• ~you have high blood pressure;
• ~a member of your immediate family has had a heart attack or stroke at a young age
(less than about the age of 50 years); in this case you could also have a higher risk of
having a heart attack or stroke;
• ~ you, or someone in your immediate family, have a high level of fat in the blood
(cholesterol ortriglycerides);
• ~you get migraines, especially migraines with aura;
• ~you have a problem with your heart (valve disorder, disturbance of the rhythm called
atrial fibrillation);
• ~youhavediabetes.

Some medicines can make Cimizt Tablets less effective in preventing pregnancy, or can
cause unexpected bleeding. These include:
• Medicines used for the treatment of:
epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
oxcarbamazepine);
tuberculosis (e.g. rifampicin);
HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as
griseofulvin, penicillin, tetracycline);
• The herbal remedy St. John's wort;
CimiztTablets may influence the effect of other medicines, e.g.
• medicinescontainingcydosporin;
• the anti-epileptic lamotrigine (this could lead to an increased frequency of
seizures).
Ask your doctor or phanmacist for advice before taking any medicine.
CimiztTablots with food and drink
CimiztTablets may be taken with or without food, ifnecessarywith a small amount of water.
Laboratory tests:
If you need a blood last, tell your doctor or the laboratory staff that you are laking the pill,
because honmone contraceptives can affect the results of some tests.
Pregnancy
If you are pregnant, do not take Cimizt Tablets. If you become pregnant while taking Cimizt
Tablets stop immediately and contact your doctor. If you want to become pregnant, you can
stop laking the pill at any time.
Ask your doctoror pha""acist for advice befora faking anymedicine.

If you have more than one of these conditions or ~any of them are particularly severe the
risk of developing a blood clot may be increased even more.

Breast-feeding
Use of Cimizt Tablets is generally not advisable when a woman is breast-feeding. If you
want to take the pill while you are breast feeding you should contactyourdoctor.
Ask your doctoror pha""acist for advice befora taking anymedicine.

If any of the above conditions change while you are using Cimizt, for example you start
smoking, a dose family member experiences a thrombosis for no known reason, or you
gain alot of weight, tell your doctor.

Drlvlng and using machines
There is no infonmation suggesting that use of Cimizt Tablets affects driving or use of
machines.

The pill and cancer
Breast cancer has been observed slightly more often in women using combination pills, but
it is not known whether this is caused by the treatment. For example it may be that more
tumours are detected in women on combination pills because they are examined by their
doctor more often. The occurrence of breast tumours becomes gradually less after stopping
the combination hormonal contraceptives. lt is important to regularly check your breasts
and you should conlactyourdoctor if you feel any lump.

CimiztTablets contain lactose
This product contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contactyourdoctor before you take this product.

In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have
been reported in pill users. Contact your doctor if you have unusually severe abdominal
pain.
Bleeding between periods
During the first few months that you are taking Cimizt Tablets, you may have unexpected
bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few
months, or if it begins after some months, your doctor must find out what is wrong.
What you must do if no bleeding occurs in the gap week
If you have taken all the tablets correctiy, have not had vomiting or severe diarrhoea and you
have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant.
Contact your doctor immediately. Do not start the next strip until you are sure that you are
not pregnant.

Other medicines and ClmlztTablots
Always tell the doctor which medicines or herbal products you are already using. Also tell
any other doctor or dentist who prescribes another medicine (or the phanmacist) that you
use Cimizt Tablets. They can tell you ~ you need to take additional contraceptive
precautions (for example condoms) and ~so. for how long.

3. HOWTOTAKECIMIZTTABLETS
Take one tablet of Cimizt Tablets every day, if necessary with a small amount of water. You
may lake the tablets with or without food, but you should lake the tablets every day around
the same time.
The strip contains 211ablets. Next to each tablet is printed the day of the week that it should
be taken. If, for example you start on a Wednesday, lake a tablet with "WED' next to it.
Follow the direction of the arrow on the strip until all21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a
stop or gap week) bleeding should begin. This is so-called 'withdrawal bleeding" usually
starts on the 2" or 3' day of the gap week.
On the 8' day after the last tablet of Cimizt (that is, after the 7 day gap week), you should
start wnh the following strip, whether your bleeding has stopped or not. This means that you
should start every strtp on the same day of the week and that the withdrawal bleed should
occur on the same days each month.
If you use Cimizt Tablets in this manner, you are also protected against pregnancy during
the 7days when you are not taking a tablet.
When can you start with tlleRrststrlp?
• If you have not used a contracep6ve with honnones in the previous month
Begin with Cimizt on the first day of the cycle (that is the first day of your period). If you
start Cimizt on the first day of your period you are immediately protected against
pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra
protective measures (for example, a condom) forthefirst7 days.











Changing from a combinaffon hormonal contraceptive, or combinaffon contraceptive
vaginal ring orpatch
You can start Cimizt preferably on the day after the last active tablet (the last tablet
containing active substances) of your previous pill, but at the latest on the day after the
tablet-free days of your previous pill (or after the last inactive tablet of your previous
pill). When changing from a combination contraceptive vaginal ring or patch, follow the
advice of your doctor.
Changing from a progestogen-only-method (progestogen-only pill, injection, implant or
a progestogen-re/easing IUD)
You may switch any day from the progestogen-only pill (from an implant or an IUD on
the day of its removal, from an injectable when the next injection would be due) but in all
of these cases use extra protective measures (for example, a condom) for the first 7
days of tablet-taking.
After amiscarriage
Follow the advice of your doctor.
Afterhaving a baby
You can start Cimizt between 21 and 28 days after having a baby. If you start later than
day 28, use a so-called barrier method (for example, a condom) during the first seven
days of Cimizt use. If, after having a baby, you have had sex before starting Cimizt
(again), be sure that you are not pregnant or wait until your next period.
Ifyou are breastfeeding and want to start Cimizt Tablets (again) afterhaving ababy
Read the section on 'Breast feeding".

Askyourdoctorwhatto do if you are not sure when to start.
If you take more Cimizt Tablets than you should
There are no reports of serious harmful resuHs of taking too many Cimizt Tablets. If you take
several tablets at once then you may have symptoms of nausea or vomiting. Young girts
may have bleeding from the vagina. If you have taken too many Cimizt Tablets, or you
discover that achild has taken some, ask your doctor or pharmacist for advice.
What to do Hyou forgetto take CimiztTablets
• If you are less than 12 hours late laking a tablet, the protection against pregnancy is
not reduced. Take the tablet as soon as you remember and then take the following
tablets again atthe usual time.
• If you are more than 12 hours late taking a tablet, the protection against pregnancy
may be reduced. The greater the number of tablets that you have forgollen, the greater
is the risk of becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the
beginning or the end of the strip. Therefore, you should keep to the following rules (see the
diagram):
• More than one tablet forgotten In this strip
Contact your doctor.
• One tabletforgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take
two tablets at the same time. Continue taking the tablets at the usual time and use extra
precautions for the next 7 days, for example, a condom. If you have had sex in the week
baforeforgetting the tablet you may be pregnant. In that case, contact your doctor.
• Onetabletforgotteninweek2
Take the forgotten tablet as soon as you remember, even if that means that you have to take
two tablets at the same time. Continue taking the tablets at the usual time. The protection
against pregnancy is not reduced, and you do not need to take extra precautions.
• Onetabletforgottenlnweek3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even Hthat means that you have to
take two tablets at the same time. Continue taking the tablets at the usual time. Instead
of taking the tablet-free period start the next strip.
Most likely, you will have a period at the end of the second strip but you may also have
light or menstruation like bleeding during the second strip.
2. You can also stop the strip and go directiyto the tablet-free period of7 days (record the
day on which you forgot your tablet). If you want to start a new strip on the day you
always start, make the tablet-free period less than 7days.
If you follow one of these two recommendations, you will remain protected against
pregnancy.


If you have forgotten any of the tablets in astrip, and you do not have bleeding in the first
tablet-free period, you may be pregnant. Contact your doctor before you start the next
strtp.

Several tablets
fiorgotten in 1 strip

Ask your doctor fiar advice

t
Yes

r+

I

in week 1

I

--+

t
Had sex in the previous week before fiorgetting?

I


No

• Take the fiorgotten tablet
• Use a barrier method (condom) for the following 7 days
• And finish strip
only 1 tablet fiorgotten
(taken more than 12 hours late)

'-'-...,.•1

in week 2

I--+

• Take the fiorgotten tablet and
• Finish the strip





Take the fiorgotten tablet and
Finish the strip
Instead of the gap week
Go straight on to the next strip
or

• Stop the strip immediately
• Begin the gap week (not longer than 7 days, including the fiorgotten tablet)
• Then go on to the next sbip

What to do in case ofvomiting orseYBre diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk
thatthe active substances in the tablet are not fully absorbed into your body. The situation is
almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from
a reserve strip as soon as possible. If possible take it within 12 hours of when you normally
take your pill. If this is not possible or 12 hours have passed, you should follow the advice
given under 'What to do if you forget to take CimiztTablets'.

Ifyou want to stop taking CimiztTablats
You can stop taking Cimizt Tablets whenever you want. If you do not want to become
pregnant, ask your doctor for advice about other reliable methods of birth control. If you
want to become pregnant, stop taking Cimizl Tablets and wait for a period before trying to
become pregnant. You will be able to calculate the expected delivery date more easily.
ffyou haveanyfurtherquestions on the use ofthis product, askyourdoctororpharmacist.

4. POSSIBLE SIDE EFFECTS
Delay of menstrual period: what you need to know
Even though it is not recommended, you can delay your menstrual period by going straight
to a new strip of Cimizl Tablets instead of the tablet-free period, and finishing it. You may
experience light or mens!Nation~ike bleeding while using this second strip. After the usual
tablet-free period of7 days, start the next strip.
You mightaskyourdoctorforadvice before deciding to delay your menstrual period.
Changing of the first day ofyourmenstrual period: what you must know
If you take the tablets according to the instructions, then your period will begin during the
tablet-free week. If you have to change this day, reduce the number of the tablet-free days
(but neverincrease them -7 is the maximum). For example, if your tablet-free days normally
begin on a Friday, and you want to change this to aTuesday (3 days eanier) start a new strtp
3 days eartierthan usual. If you make the tablet-free interval very short (for example, 3days
or less) you may not have any bleeding during these days. You may then experience light or
menstruation-like bleeding.
ffyou aranotsura what to do, consult your doctor.

Like all medicines, Cimizl Tablets can cause side effects, aHhough not everybody gets
them. If you get any side effect, particularly Hsevere and persistent, or have any change to
your health that you think may be due to Cimizt, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood
clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking
combined hormonal contraceptives. For more detailed information on the different risks
from taking combined hormonal contraceptives please see section 2 'What you need to
know before you take CimiztTablets'.
Serlous reactions
More serious reactions associated with combined hormonal contraceptive pills are detailed
above in section 2 under 'Blood Clots' and 'The pill and cance~. Please read these
subsections carefully, and Hyou have any questions, askyourdoctor.

The following serious side effects have been reported in women using the pill: Crohn's
disease or ulcerative colitis (chronic inflammatory bowel diseases), systemic lupus
erythematosus (SLE, a disease of the connective tissue), epilepsy, the rash known as
herpes gestationis, chorea (a movement disease), a blood disorder called haemolytic
uraemic syndrome - HUS (a disorder where blood clots cause the kidneys to fail), brown
patches on the face and body (chloasma), movement disorder called Sydenham's chorea,
yellowing of the skin, gynaecological disorders (endometriosis, uterine myoma).

What Cimizttablets look like and contents of the pack
Each tablet is round, while to off-white, uncoated, biconvex, debossed with '142' on one
side and other side plain.

Other possible side effects
The following side effects have been reported in women using the pill, which can occur in
the first few months after starting Cimizl Tablets, but they usually stop once your body has
adjusted to the pill. The most commonly reported side effects (more than 1in every 10 users
may be affected) are irregular bleeding and weight gain.

MartketingAuthorisation Holder
Momingside Healthcare Lld,
115 Narborough Road, Leicester, LE3 OPA, United Kingdom.

Common or uncommon (between 1and 100 in every 1,000 useTB may be affected): none or
reduced bleeding, tender breasts, breast enlargement, breast pain, decreased sexual
desire, depression, headache, nervousness, migraine, dizziness, nausea, vomiting, acne,
rash, nettle-rash (urticaria), fluid retention, high blood pressure.

Rare {between 1and 10 in every 10,000 useTB may be affected), vaginal candidiasis (fungal
infection), impaired hearing (otosclerosis), thromboembolism, hypersensitivity, increased
sexual desire, eye irritation due to contact lens, loss of hair (alopecia), itching, skin
disorders (erythema nodosum - a skin disease associated with joint pain, fever,
hypersensitivity, or infection, and characterized by small, painful, pink to blue nodules under
the skin and on the shins that tend to recur; erythema multiforme - a skin disease
characterized by solid raised spots on the skin or fluid-filled blistars lesions and reddening
or discoloration of the skin often in concentric zones about the lesions), vaginal discharge,
breast discharge, harmful blood clots in avein orarteryforexample:
• inalegorfool(i.e.DYT];
• in alung (i.e. PE);
• heartattack;
• stroke;
• mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack
(TIA);
• blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any other conditions that
increase this risk (See section 2 for more information on the conditions that increase risk for
blood clots and the symptoms of a blood clot).
Before you have any blood lasts
Tell your doctor or the laboratory staff that you are taking the pill, because oral
contraceptives can affect the results of some tests.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects
not listed in this leaflet.

5. HOWTOSTORECIMIZTTABLETS
Keep this medicine out ofthe sight and reach ofchildren.
Do not store above 25"C. Store in the original package in order to protect from moisture and
light.

Expiry data
Do nof use this medicine al!er the expiry date which is stated on the package al!er "EXP'.
The expiry date refeTB to the last day ofthat month.
Do notthrow away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What CimiztTablats contain
The active substances are desogestrel and ethinylestradiol.
The other ingredients are:
All-rac-alpha-tocopherol, potato starch, povidone (E1201), stearic acid (E570), silica
colloidal anhydrous (E551) and lactose anhydrous.

Each strip of Cimizt Tablets contains 21 white tablets.
Each boxofCimiztTabletscontains 1, 3or6stripsof21 tablets.
Not all pack sizes may be marketed.

Manufacturer
Momingside Pharmaceuticals Ltd,
5 Pavilion Way, Castle Business Park, Loughborough, Leicestershire,
LE11 5GW, United Kingdom.
This leaflet is available in large font or audio format upon request.
Thlslaafletwaslast revised In March 2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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